WO2019226817A1 - Dispositifs, systèmes et procédés pour résection tissulaire - Google Patents

Dispositifs, systèmes et procédés pour résection tissulaire Download PDF

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Publication number
WO2019226817A1
WO2019226817A1 PCT/US2019/033595 US2019033595W WO2019226817A1 WO 2019226817 A1 WO2019226817 A1 WO 2019226817A1 US 2019033595 W US2019033595 W US 2019033595W WO 2019226817 A1 WO2019226817 A1 WO 2019226817A1
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WO
WIPO (PCT)
Prior art keywords
tissue
resection
arms
lumen
elongate body
Prior art date
Application number
PCT/US2019/033595
Other languages
English (en)
Inventor
John B. Golden
Caleb VALDES
Austin G. Johnson
Chris JICKA
Serena SCOTT
Michael K. FORD
Kyle P. Moore
Janice COURTOIS
Prashanth SOMASUNDARAM
Original Assignee
Boston Scientific Scimed, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boston Scientific Scimed, Inc. filed Critical Boston Scientific Scimed, Inc.
Publication of WO2019226817A1 publication Critical patent/WO2019226817A1/fr

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
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    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122—Clamps or clips, e.g. for the umbilical cord
    • A61B17/1227—Spring clips
    • A—HUMAN NECESSITIES
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    • A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/34—Trocars; Puncturing needles
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2017/00646—Type of implements
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    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12009—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
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    • A61B17/32—Surgical cutting instruments
    • A61B2017/320064—Surgical cutting instruments with tissue or sample retaining means

Definitions

  • the present disclosure relates generally to devices, systems, and methods for performing endoscopic procedures, and, more particularly, tissue resection devices for endoscopic mucosal resection (EMR) and/or endoscopic submucosal dissection (ESD) procedures, including such devices, system and methods to achieve partially or fully circumferential endoscopic full thickness resection (eFTR), tissue closure and/or tissue apposition.
  • EMR endoscopic mucosal resection
  • ESD endoscopic submucosal dissection
  • Endoscopic mucosal resection (EMR) and/or endoscopic submucosal dissection (ESD) procedures may be used to remove benign or diseased tissue, e.g., lesions, cancerous tumors, and/or other anomalies, from a patient’s gastrointestinal system.
  • EMR Endoscopic mucosal resection
  • ESD endoscopic submucosal dissection
  • FTR full thickness resection
  • FTR procedures may pose additional challenges such as anatomical difficulties of removing tissue adjacent critical internal organs and other sensitive structures, as well as risk of post-operative leakage, potentially increasing a patient’s health risk in undergoing an FTR procedure.
  • a device for tissue resection from within a body lumen may include an elongate body having a cavity at a distal end, and a tissue retractor extendable distally from the distal end of the elongate body and including an expansion mechanism.
  • the expansion mechanism may include a plurality of arms each having a first end coupled around a distal cap and expandable radially outward from the distal cap, such that an anchoring mechanism on a second end of the arms may be engageable with selected tissue for resection of the body lumen.
  • the device may further include a tissue resecting device.
  • the tissue resection device may further include a sheath attached to the tissue retractor and extendable from the elongate body.
  • the expansion mechanism may further include a plurality of connectors each having a first end coupled to the sheath and a second end coupled to a respective arm.
  • the expansion mechanism may be configured to radially expand symmetrically around the distal cap and the sheath.
  • the expansion mechanism may be configured to radially expand asymmetrically around the distal cap and the sheath.
  • the tissue closure device may be disposed on an outer surface of the distal end of the elongate body.
  • the tissue retractor may be configured to extend through a wall of the body lumen, the plurality of arms positioned substantially parallel to the elongate body, and engage the selected tissue for resection when the plurality of arms is expanded radially.
  • the tissue resecting device may be an internal shear edge of the cavity, a shear proximal edge of the distal cap, or a shear edge of a distal end of the elongate body, or combinations thereof.
  • the tissue resecting device may be a mechanical cutting tool or a cauterizing tool, or combinations thereof.
  • a system for tissue resection from within a body lumen may include a lumen extendable into a patient.
  • the lumen may include one or more working channels for delivering accessories to selected tissue for resection of the body lumen.
  • the system may further include a tissue resection device deliverable over the lumen.
  • the tissue resection device may include an elongate body having a cavity at a distal end.
  • the tissue resection device may further include a tissue retractor extendable distally from the distal end of the elongate body, and may include an expansion mechanism.
  • the expansion mechanism may include a plurality of arms each having a first end coupled circumferentially around a distal cap and expandable radially outward from the distal cap, such that an anchoring mechanism on a second end of each arm may be engageable with the selected tissue for resection of the body lumen.
  • the tissue resection device may further include a tissue resecting device.
  • the tissue retractor may be configured to extend through the selected tissue for resection to an outer surface of the body lumen.
  • the plurality of arms may be positioned substantially parallel to the elongate body, and may engage with the outer surface when the plurality of arms is expanded radially.
  • the tissue retractor may be configured to retract the arms substantially parallel to the elongate body while the anchoring mechanisms are engaged with the outer surface of the selected tissue for resection.
  • the tissue retractor may be configured to retract proximally towards the elongate body such that the arms are receivable in the cavity.
  • the tissue resection system may further include a sheath attached to the tissue retractor and extendable from the elongate body.
  • the sheath and the lumen may be coaxial such that the sheath may be extendable and retractable with respect to the elongate body along the lumen.
  • a method for resection of selected tissue in a body lumen of a patient may include positioning a distal end of a lumen in the body lumen of the patient to the selected tissue for resection, and extending a tissue resection device to the selected tissue for resection.
  • the tissue resection device may include an elongate body having a cavity at a distal end and a tissue retractor extendable distally from the distal end of the elongate body.
  • the method may further include advancing the tissue retractor from an inner surface of the selected tissue to an outer surface of the selected tissue.
  • the method may further include radially expanding a plurality of arms on an expansion mechanism of the tissue retractor, and engaging an anchoring mechanism on each arm to the tissue selected for resection.
  • the method may further include retracting the plurality of arms radially inward while the anchoring mechanisms are engaged to the selected tissue for resection, to capture the selected tissue.
  • the method may further include retracting the tissue retractor in proximally toward the elongate body such that the captured tissue is received within the cavity of the elongate body, and resecting the selected tissue from the body lumen.
  • the method may further include piercing the inner surface of the selected tissue by an accessory delivered by the lumen and extending the lumen through an opening to the outer surface of the selected tissue.
  • the method may further include resecting the selected tissue by an internal shear edge of the cavity, a shear proximal edge of the distal cap, or a shear edge of a distal end of the elongate body, or combinations thereof.
  • the expansion mechanism may further include a plurality of connectors each having a first end coupled to a sheath distally extendable from the elongate body, and a second end may be coupled to a respective arm, such that the plurality of arms may be radially expandable by articulation of the connectors.
  • the method may further include closing remaining tissue of the body lumen by a tissue closure device, and the tissue closure device may be disposed on an outer surface of the distal end of the elongate body.
  • FIG. 1 illustrates a body lumen of a patient
  • FIGS. 2A-2B illustrate an exemplary embodiment of a tissue resection device in accordance with the present disclosure
  • FIGS. 3A-3C illustrate exemplary embodiments of a tissue retractor of a tissue resection device in accordance with the present disclosure
  • FIGS. 3D-3E illustrate sectional views of an exemplary embodiment of a tissue retractor of a tissue resection device in an open position and a closed position in accordance with the present disclosure
  • FIGS. 3F-3G illustrate perspective views of an exemplary embodiment of a tissue retractor of a tissue resection device in an open position and a closed position in accordance with the present disclosure
  • FIG. 3H illustrates an exemplary embodiment of connectors of a tissue retractor of a tissue resection device in accordance with the present disclosure
  • FIGS. 3I-3J illustrate exemplary embodiments of a tissue retractor of a tissue resection device in an open position and a closed position in accordance with the present disclosure
  • FIGS. 4A-4G illustrate an exemplary tissue resection system and process for tissue resection in accordance with the present disclosure
  • FIG. 5 illustrates an exemplary embodiment of a tissue resection device in accordance with the present disclosure.
  • references to“proximal” may be defined as an end of the systems and devices closest to the entry point of the patient and“distal” may be defined as an end of the systems and devices closest to the desired location of the system and devices in the patient (e.g., a patient’s gastrointestinal system).
  • patients with diseased or other tissue in the gastrointestinal system may require resection.
  • various sized lesions are illustrated in a body lumen (e.g., gastrointestinal system) of a patient.
  • a body lumen e.g., gastrointestinal system
  • earlier stages of diseased tissue may not extend through all the layers of the body lumen, which may allow for resection of only the affected tissue layers.
  • resection of the entire tissue portion e.g., full thickness resection
  • Exemplary embodiments of devices, systems, and methods for partial or full thickness tissue resection in accordance with the present disclosure may allow for a selected tissue section containing diseased tissue to be contained and resected from surrounding tissue, the surrounding tissue then being joined together to close a gap formed by the resection of the selected tissue.
  • the tissue resection may be fully circumferential, e.g., extending 360° around a body lumen.
  • the tissue resection may be partially circumferential, e.g., extending less than 360° around a body lumen.
  • exemplary embodiments of the present disclosure may encompass resecting, dissecting, removing, ablating, cutting vaporizing, freezing, etc., and may be full thickness, partial thickness, and in instances of a procedure occurring in a body lumen, may be partial and/or fully circumferential.
  • an expandable device may be delivered from within a body lumen through a wall of the body lumen, e.g., to an outer surface of a body lumen, for capturing a selected tissue for resection in the device.
  • the device may be utilized in partial and/or full circumferential full thickness resection procedures.
  • selected tissue for resection may be an area of diseased tissue, e.g., including tumors and/or lesions, as well as a portion of healthy tissue immediately adjacent the diseased tissue. A portion of healthy tissue may be resected to minimize a risk of not fully capturing the diseased tissue and/or dislodging diseased tissue cells to potentially contaminate another tissue region.
  • the selected tissue for resection may include a benign cyst or legion.
  • the body lumen is described with respect to the gastrointestinal system, including but not limited to an intestine, colon, and/or duodenum, it is understood that exemplary embodiments of devices, systems, and methods of the present disclosure may apply to any body lumen in a patient.
  • the selected tissue may be in a body lumen such as an intestine, colon, and/or other gastrointestinal system.
  • the resection system may be configured for full thickness resection of a large intestine, although it is envisioned that the resection device may be configured for other anatomical resecting as well.
  • the device 200 may be configured to extend along an axis 202 and may have a proximal end 200a and a distal end 200b.
  • the device 200 may include an elongate body 205 having a proximal end 205 a and a distal end 205b.
  • the body 205 may be substantially cylindrical and may extend along the axis 202.
  • the device 200 may include a handle 210 having a proximal end 2l0a and a distal end 2l0b, the distal end 2l0b of the handle 210 being coupleable to the proximal end 205a of the body 205.
  • the body 205 may include a cavity 215 for capturing and/or receiving resected tissue 220, and/or receiving at least a portion of a tissue retractor 230.
  • a lumen 225 may be extendable through the body 205 along the axis 202, and may be configured to extend through the selected tissue for resection 220, e.g., the lumen 225 may be extendable from an inner surface 220a of the tissue 220 to an outer surface 220b of the tissue 220 in a distal direction along the axis 202.
  • the lumen 225 may have one or more working channels for additional accessories to be used at the site of the selected tissue for resection, and in some embodiments may be a Boston Scientific SpyScopeTM catheter.
  • a tissue retractor 230 may be disposed distally of the cavity 215 and may be deliverable through the selected tissue for resection 220, e.g., to the outer surface 220b of the tissue 220.
  • a tissue closure device 235 may be disposed on an outer surface 240 of the body 205. In some embodiments, the tissue closure device 235 may be one or more clips, clamps, bands, rings, sutures, and/or other mechanical fastener to close the tissue after resection.
  • the tissue retractor 230 may be releasably attachable to the cavity 215 by a sheath 245 along the axis 202, to extend the tissue retractor 230 in a distal direction along the axis 202 to the outer surface 220b of the selected tissue for resection 220 separate from the cavity 215.
  • the cavity 215 may remain inside the body lumen while the tissue retractor 230 is extendable to the outside of the body lumen.
  • the sheath 245 may be coaxial to the lumen 225, so that the tissue retractor 230 may be retractable in a proximal direction along the axis 202 to capture the selected tissue for resection 220, at least a portion of the tissue retractor 230 and the selected tissue for resection 220 being retractable into the cavity 215.
  • the sheath 245 may be attached to the handle 210 for manipulation of the tissue retractor 230 by a medical professional.
  • a handle 210 may have controls for axially extending the tissue retractor 230 and independently opening and/or closing the tissue retractor 230.
  • FIGS. 3A-3J exemplary embodiments of a tissue retractor are illustrated in accordance with the present disclosure.
  • FIGS. 3A-3C, and 3E illustrate exemplary embodiments of the tissue retractor 230 in an extended position 300, 300’ and a retracted position 305, e.g., during deployment in a body lumen.
  • FIG. 3D illustrates an exemplary embodiment of the tissue retractor 230 in a closed position, e.g., prior to deployment in a body lumen.
  • the tissue retractor 230 may be attached to the sheath 245 for extending through the selected tissue for resection 220 and retracting back to the cavity 215 of the body 205.
  • the tissue retractor 230 may include a distal cap 315, attachable at the distal end 205b of the body 205.
  • the distal cap 315 may be coaxial to the sheath 245, e.g., along axis 302.
  • the distal cap 315 may be a frustoconical shape, e.g., having a tapered outer surface 320, so that the distal cap 315 may have a smaller diameter 320b at the distal end 3l5b of the distal cap 315 and a larger diameter 320a at the proximal end 3l5a of the distal cap 315.
  • a frustoconical shape may be advantageous for extending the tissue retractor 230 through the tissue 220.
  • the smaller diameter 320b may be inserted in the tissue 220 after a tissue penetration device penetrates the tissue to create an opening 325, so that the opening 325 conforms to the tapered outer surface 320 of the distal cap 315 as it is passed through the opening 325. It is also understood that the distal end 3l5b of the distal cap 315 may have a sharp edge for penetrating (e.g., cutting) through the tissue 220.
  • the distal cap 315 may be substantially hollow, for receiving at least a portion of an expansion mechanism 330, 330’.
  • the expansion mechanism 330 may include a plurality of arms 335, e.g., 335a, 335b, ... 335n, for extension on the outer surface 220b of the selected tissue for resection 220. It is understood that any number“n” of arms 335 may be included in the tissue retractor 230.
  • the arms 335 may be coupled
  • the arms 335 may be coupled to allow movement, including but not limited to rotational, pivoting, telescoping, and/or twisting movement.
  • the arms 335 may be hingedly, pivotably, and/or otherwise rotatably coupled to the hub 304.
  • the arms 335 may have a first end 340a and a second end 340b, the first end 340a being coupled to the hub 304, and the second end 340b contactable with the outer surface 220b of the selected tissue for resection 220.
  • the second end 340b may include an anchoring mechanism 345 to engage (e.g., grasp) the selected tissue for resection 220.
  • the anchoring mechanism 345 may be a hook, barb, clip, clamp, and the like.
  • the arms 335 may be radially expandable from the distal cap 315 and/or the sheath 245.
  • Each arm 335a, 335b, ... 335n may be articulatable independently of each other and/or may all be articulatable as a group.
  • the arms 335 may be radially expandable symmetrically around the sheath 245 and/or the distal cap 315.
  • the selected tissue for resection 220 may be symmetrically surrounding the sheath 245 and/or the distal cap 315.
  • arms 335’ may be radially expandable asymmetrically from the distal cap 315.
  • the arms 335, 335’ may be configured of differing lengths, may be telescopic and/or foldable for adjusting to a selected length, so the expansion mechanism 330, 330’ may be configured to extend or expand each arm 335’a, 335’b, ... 335’n independently of each other to the selected length. This may be advantageous when it is desired to extend the tissue retractor 230 through the tissue 220 proximate to a lesion, cyst, tumor, or other diseased tissue 350 without disturbing and/or dislodging the diseased tissue cells.
  • the selected tissue for resection 220 may extend asymmetrically around the tissue retractor 230.
  • an asymmetrical expansion mechanism 330’ may be advantageous for the anchor mechanism at the second end 340b of the arms 335 to engage to a portion of healthy tissue 355 surrounding the diseased tissue 350 (e.g., comprising a selected tissue for resection).
  • the expansion mechanism 330, 330’ may further include connectors 360 attached to the first end 340a of the arms 335, 335’, the sheath 245 and/or the hub 304 (see FIGS. 3D- 3H).
  • the connectors 360 may be coupled to the sheath 245 at a first end 340a and the distal cap 315 and/or the arms 335, 335’ at a second end 360b.
  • the connectors 360 may be hingedly or rotatably attached to the distal cap 315, e.g., circumferentially around the proximal end 3l5a of the distal cap 315, so the arms 335, 335’ may be expandable radially (e.g., in a direction illustrated by arrows 306) from the distal cap 315 and/or the sheath 245.
  • additional connectors 365 may be coupled between the hub 304 and the first end of the arm 340a, and a connector 360 may be coupled between the first end of the arm 340a and a shaft 308.
  • the connector 360 and additional connectors 365 may be articulatable independently of each other, e.g., the arms 335 may be articulatable about an axis 360a, which may be a connection between the connector and the first end of the arm 340a, and an axis 365 a, which may be a connection between the additional connector 365 and the first end of the arm 340a.
  • the connector 360 may also be hingedly or rotatably coupled to the shaft 308, e.g., about an axis 308a.
  • the additional connector 365 may be coupled to the hub 304, either fixedly, or hingedly or rotatably.
  • the connectors 360 may articulate the arms 335, 335’ to an extended and/or retracted position, e.g., similar to an umbrella.
  • the expansion mechanism 330, 330’ may be operable by a coaxial shaft 308, in which the connectors 360 are coupled (e.g., hingedly or rotatably) for manipulating between an extended and retracted position.
  • a medical professional may manipulate a proximal end of the shaft 308 (e.g., external to a patient), to extend and/or retract the expansion mechanism 330, 330’.
  • the expansion mechanism 330, 330’ may articulate the connectors 360 and the arms 335, 335’, e.g., relative to the sheath 245, shaft 308, hub 304, and/or the distal cap 315, to an extended position 300, 300’ as shown in FIGS. 3A-3B, 3E, and 3G.
  • the expansion mechanism 330, 330’ may articulate the connectors 360 and/or the additional connectors 365 via the shaft 308 and hub 304 for manipulating the arms 335, 335’, e.g., relative to the sheath 245, shaft 308, hub 304, and/or the distal cap 315, to a retracted position 305 as shown in FIG. 3C, 3F, and/or in a closed position 317 as shown in FIG. 3D.
  • the selected tissue for resection 220 may be capturable between the arms 335, 335’ by retracting the arms to a radially inward position.
  • the retracted position 305 may have the arms 335, 335’ substantially parallel to the sheath 245 along the axis 302, so that the selected tissue for resection 220 is captured between the arms 335, 335’ and the sheath 245 and shaft 308.
  • the expansion mechanism 330, 330’ may also be in a retracted position 305 when extending out of the cavity 215, e.g., for positioning through the tissue.
  • the sheath 245, shaft 308, expansion mechanism 330, 330’, and distal cap 315 may be extendable along the axis 302 in a distal direction as indicated by arrow 312 (see FIG. 3E).
  • the arms 335, 335’ may also be substantially parallel to the sheath 245 along the axis 302 to fit within the cavity 215.
  • the arms 335 may be adjustable, e.g., telescoping.
  • a length of the arm 335 between the first end 340a of the arm and the second end 340b of the arm may be variable.
  • the arms 335 may be adjustable to accommodate different amounts of selected tissue for resection, and/or capturing desired areas of tissue.
  • the arms 335 may have a first portion 314 and a second portion 316.
  • the second portion 316 may be adjustable relative to the first portion 314, e.g., the second portion 316 may telescope from the first portion 314.
  • Adjustable arms 335 may allow for symmetrical or asymmetrical positioning of the expansion mechanism for capturing the selected tissue.
  • FIGS. 3I-3J illustrate other exemplary embodiments of an expansion mechanism in accordance with the present disclosure.
  • arms 335 may be connected to a pullwire 370, e.g., at a connection 375.
  • the pullwire 370 may extend to the proximal end of the device, e.g., external to the patient for manipulation by a medical professional.
  • the pullwire 370 When the pullwire 370 is pulled in a proximal direction (e.g., in a direction indicated by arrows 377), for example, the arms 335 may articulate to an extended position relative to the sheath 245.
  • a proximal direction e.g., in a direction indicated by arrows 377
  • a sheath 245’ may be movable relative to a hub 304’.
  • at least a portion of the hub 304’ may be receivable within a portion of the sheath 245’.
  • the arms 335 may be coupled to a connector 360’ and/or an additional connector 365’, where the connector 360’ may be also coupled to the sheath 245’ and the additional connector 365’ may be also coupled to the hub 304’.
  • the connector 360’ and additional connector 365’ may be hingedly or rotatably coupled to the arms 335, sheath 245’, and/or hub 304’.
  • the hub 304’ may be disposed in a first position 380 relative to the sheath 245’.
  • the medical professional articulates the sheath 245’, at least a portion of the hub 304’ may be received within the sheath 245’ to a second position 385, resulting in an extension of the arms 335 via the connectors 360’ and additional connectors 365’.
  • the arms 335 may be rotatable in a direction indicated by arrows 306’. It may be understood that the connectors 360’ and additional connectors 365’ may be operable in a manner similar to the connectors 360 and additional connectors 365 (see FIG. 3H).
  • the tissue resection system 405 may be extendable along an exterior surface 225a of a lumen 225, or a catheter, in a patient, e.g., in a body lumen of the patient, to a location of a selected tissue for resection.
  • the distal end 205b of the body 205 may include the cavity 215 and the tissue retractor 230.
  • the expansion mechanism 330, 330’ may be at least partially received within the cavity 215, so that the distal cap 315 is adjacent the cavity 215.
  • a tissue closure device 235 may be disposed on the outer surface 240 of the body 205.
  • the system 405 may be deliverable in the body lumen by a navigation and/or visualization device, which in some embodiments may be included in the lumen 225.
  • the visualization device may be an optical wand, an integrated camera chip, an ultrasonic device, an endoscope (e.g., SpyScopeTM catheter), and/or other known visualization techniques including but not limited to direct visualization, ultrasonic imaging, and/or fluoroscopy and/or radiopaque markers.
  • the system 405 may have an independent steering system, although it is also envisioned that the system 405 may use a steerable device (e.g., guide wire technique) in the body lumen as a guide.
  • a steerable device e.g., guide wire technique
  • an imaging device may be included on a distal face 410 of the lumen 225, so that the tissue 220 may be visualized.
  • the system 405 may be connectable substantially parallel and adjacent to another imaging device (see FIG. 5).
  • additional device 505 may be attachable by any known mechanisms, including but not limited to a clip, clamp, or other attachment mechanism or sleeve.
  • the additional device 505 may include one or more imaging devices 510 and/or lighting devices 515 on a distal face 520.
  • the additional device 505 may provide additional visualization and/or navigation for the medical professional.
  • the lumen 225 may provide visualization to an outer surface 220b of the selected tissue, and the additional device 505 may provide visualization to an inner surface 220a of the selected tissue. This may allow the medical professional to ensure correct positioning and capture with respect to the selected tissue 220.
  • a tissue penetrating device 415 may be extendable through the lumen 225, e.g., through a working channel, and may extend out the distal face 410 of the lumen 225.
  • the tissue penetrating device may be extendable through a working channel of a visualization device, itself extendable through the lumen, e.g., so that penetration of the body lumen may be visualized as it is performed, such as a penetrating device extendable through a working channel of a Spy scope catheter.
  • the tissue penetrating device 415 may be any tool for piercing, or penetrating tissue, such a knife, needle, blade, cautery, laser, and/or ultrasonic tool.
  • the tissue penetrating device may be used to pierce through the selected tissue for resection 220, so that the lumen 225 and at least a portion of the system 405 may be extended to the outer surface 220b of the selected tissue 220, as shown in FIG. 4C at step 400c.
  • other accessories may be deliverable through the lumen 225, e.g., by one or more working channels, for use by the medical professional.
  • a fluid delivery device may deliver fluids (e.g, saline or C02 gas) to insufflate an area outside of the body lumen.
  • adjacent lymph nodes may be examined and/or biopsied by grasping tools and collected by the lumen 225.
  • the tissue retractor 230 may be extendable in a distal direction along an axis 402 from the body 205 and advanced through the tissue 220 along the lumen 225 to create an opening 325.
  • the axis 402 may be substantially perpendicular to the body lumen (e.g., substantially perpendicular to axis 202) to extend transversely through the tissue 220.
  • the lumen 225 may extend through the tissue 220 as it is pierced or penetrated, to maintain the opening 325.
  • the distal cap 315 may dilate the opening 325 by the frustoconical shape (e.g., the tapered outer surface 320) of the outer surface 320, so that the tissue retractor 230 may be advance through the tissue 220.
  • an independent dilation device may be used, including but not limited to a balloon and/or a blunt dissection tool for passage of the tissue retractor 230.
  • the tissue retractor 230 may be fully extended to the outer surface 220b of the selected tissue for resection 220 by the sheath 245.
  • the arms 335, 335’ may be deployable circumferentially around the proximal end 3l5a of the distal cap 315. As described above with respect to FIGS. 3A-3J, the arms 335, 335’ may be deployable symmetrically and/or asymmetrically to surround the selected tissue for resection 220.
  • a perimeter may be formed on the outer surface 220b to surround the selected tissue for resection 220.
  • the perimeter may be substantially circular, elliptical, and/or circumferential, but is understood that the perimeter may be any shaped formed by the second end 340b of the arms 335, 335’.
  • the arms 335, 335’ may be telescopic, and may be independently articulatable to form any shape radially around the distal cap 315 and/or the sheath 245.
  • the anchoring mechanism 345 on each arm 335, 335’ may engage (e.g., grasp or attach) to the outer surface 220b of the tissue selected for resection 220 without damaging the tissue.
  • the arms 335, 335’ may be retracted radially inward, gathering and capturing the selected tissue for resection 220 between the arms 335, 335’ and the sheath 245.
  • the selected tissue for resection 220 (for example, including a portion of healthy tissue 355 as well as a selected cyst, tumor, lesion, or other diseased tissue 350) may be captured by the tissue retractor 230 and may be moved in proximal direction along axis 402 towards the cavity 215 by the sheath 245.
  • the tissue retractor with expansion mechanism may be extendable and/or retractable as needed to ensure all the selected tissue for resection is captured by the arms 335, 335’.
  • the tissue retractor 230 may be retracted in a proximal direction along the axis 402 into the cavity 215 of the body 205.
  • the selected tissue for resection 220 is also drawn into the cavity 215.
  • the lumen 225 may be fully retracted, although in other embodiments the lumen 225 may remain at the location for visualization of the resection and closure procedures.
  • cavity 215 may include an internal edge 250 for resecting the selected tissue 220 (see FIGS. 2A-2B).
  • the distal cap 315 may clamp the selected tissue 220 for removal against the device, and the internal edge may be advanced in a distal direction to separate, or resect, the selected tissue.
  • an edge 420 of the cavity 215 may be a shear edge, so that as the tissue 220 is drawn into the cavity 215, the edge 420 resects, or separates, the selected tissue.
  • an edge 425 of the distal cap 315 e.g., at the proximal end 3l5a, may be a shear edge, so that as the tissue 220 is drawn into the cavity, the edge 425 of the distal cap 315 resects, or separates, the selected tissue.
  • tissue retractor 230 When the tissue retractor 230 is retracted in proximal direction toward the body 205, at least a portion of the expansion mechanism may be received within the cavity, e.g., so that the proximal edge 425 of the distal cap 315 is adjacent the distal edge 420 of the cavity 215.
  • Edges 215, 420, and/or 425 may be alternatives to each other and/or may be used in any combination for tissue resection.
  • tissue resection may occur when a sufficient amount of force is applied to the tissue retractor 230 to cleanly resect the tissue.
  • the tissue resecting device is a blade
  • the blade may be formed in any shape, including but not limited to a straight blade edge, a tapered blade edge, crenellated, and/or saw tooth.
  • shear edges and/or blades may be configured to mate together.
  • a cauterizing tool or other electrical cutting device may be used to resect the selected tissue 220.
  • the selected tissue may be resected prior to deployment of a tissue closure device, e.g., tissue closure device 235.
  • tissue closure device e.g., clips and/or suturing
  • the selected tissue may be resected concurrently with deployment of the tissue closure device.
  • the selected tissue may be resected after deployment of the tissue closure device.
  • the tissue closure device 235 may be disposed on the outer surface 240 of the body 205, and may be deployable by advancing the closure device in a distal direction along the axis 402.
  • the tissue closure device 235 When the tissue retractor 230 is retracted in a proximal direction into the cavity 215, the tissue closure device 235 may be advanced to the distal cap 315.
  • the frustoconical shape e.g., the tapered portion of the outer surface 320, may allow the tissue closure device 235 to slide off the distal end 205b of the body 205 to secure together edges 440 of the remaining body lumen tissue 445.
  • the tissue closure device 235 may be formed of a material having an elasticity, spring, and/or shape memory, and may be held on the body 205 in tension. For example, as indicated at reference numeral 430 in FIG. 4F, at least a portion of the tissue closure device is held in an open position so that the tissue closure device is in tension. Frictional forces between the tissue closure device 235 and the body 205 may also hold the tissue closure device 235 stationary on the body 205 until the medical professional desires to deploy the tissue closure device 235. When the tissue closure device 235 is advanced distally to engage the tissue closure device 235 around the remaining body lumen tissue, at least a portion of the tissue closure device 235 may adjust to a relaxed state as shown at reference numeral 435 in FIG. 4G.
  • the tissue closure device 235 may be closed around the edges 440 of the remaining body lumen tissue 445.
  • at least a portion of the tissue closure device 235 may spring radially inward to secure the edges 440 of the remaining body lumen tissue 445.
  • the spring force of the tissue closure device 235 may be sufficient to prevent slippage on the remaining body lumen tissue 445.
  • the tissue closure device 235 may be configured to minimize and/or prevent tissue damage, e.g., tearing.
  • Coupled and “connected” along with their derivatives. These terms are not intended as synonyms for each other. For example, some embodiments may be described using the terms“connected” and/or “coupled” to indicate that two or more elements are in direct physical or electrical contact with each other. The term“coupled,” however, may also mean that two or more elements are not in direct contact with each other, but still co-operate or interact with each other.

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Abstract

Des modes de réalisation donnés à titre d'exemple de la présente invention concernent des dispositifs, des systèmes et des procédés de résection tissulaire dans une lumière corporelle d'un patient, et peuvent comprendre un corps allongé ayant une cavité au niveau d'une extrémité distale et un écarteur de tissu extensible de manière distale à partir de l'extrémité distale du corps allongé. L'écarteur de tissu peut comprendre un mécanisme d'expansion. Le mécanisme d'expansion peut comprendre une pluralité de bras ayant chacun une première extrémité couplée autour d'un capuchon distal et extensible radialement vers l'extérieur à partir du capuchon distal de telle sorte qu'un mécanisme d'ancrage sur une seconde extrémité des bras peut venir en prise avec un tissu sélectionné pour une résection de la lumière corporelle. Le dispositif de résection de tissu peut en outre comprendre un dispositif de résection de tissu.
PCT/US2019/033595 2018-05-23 2019-05-22 Dispositifs, systèmes et procédés pour résection tissulaire WO2019226817A1 (fr)

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US20190357933A1 (en) 2019-11-28
US20220346823A1 (en) 2022-11-03

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